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510(k) Data Aggregation

    K Number
    K170058
    Device Name
    TheraView TBI
    Date Cleared
    2017-03-03

    (56 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cablon Medical B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment. Images maybe stored to hard disk for processing, analysis and hardcopy. This includes an automated border detection for field size and shape verification and a semi-automated overlay function of an anatomical template reference adding enhanced level of on-line assurance for image verification and comparison.
    Device Description
    Digital Portal imaging system designed to allow pre-treatment verification and real time viewing of the radiation therapy treatment. Images maybe stored to hard disk for processing, analysis and hardcopy. This includes an automated border detection for field size and shape verification and a semi-automated overlay function of an anatomical template reference adding enhanced level of on-line assurance for image verification and comparison.
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